Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2% and 0.5% has an estimated market size of US $80 million for twelve months ending December 2020 according to IQVIA
Zydus was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Ibrutinib Capsules, 70 mg.
ranules now has a total of 38 ANDA approvals from US FDA.
The company will review FDA's response and decide on appropriate next steps soon.
It is used to treat low blood pressure that causes severe dizziness or a lightheaded feeling.
SFDA nod marks company’s strategic entry into high-value specialty oncology injectables as it targets expanding stem cell transplant and haemato-oncology market in the GCC region
Biologics manufacturing veteran brings over two decades of expertise in biosimilars, GMP operations, and large-scale biopharmaceutical manufacturing
Net profit stood at Rs. 921 crore for the quarter, while Europe revenues surged 30.2% YoY to Rs. 2,795 crore
The product has received tentative USFDA approval, Health Canada notice of compliance, and Indian regulatory approval
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